In This Era Of COVID and Trump - Just What The Doctor Ordered

[dales]

Johnson & Johnson spray approved for treating suicidal people

Cynthia Koons, Bloomberg Published 7:09 am PDT, Monday, August 3, 2020


The Food and Drug Administration approval means the quick-acting nasal spray will be available to people with suicidal thoughts and a plan to put them into action, said Michelle Kramer, vice president of J&J's U.S. neuroscience medical-affairs unit. That constitutes 11% to 12% of as many as 6 million Americans who have treatment-resistant depression.


Spravato has been used by about 6,000 people for treatment-resistant depression since its approval in March 2019, Kramer said. J&J's decision to study it in depressed people actively contemplating suicide bucks a trend among drugmakers who routinely exclude such patients from trials.

Part of the thinking behind the decision was that Spravato's ability to act quickly could mean it works differently than older antidepressants that can take weeks to kick in, Kramer said. In its studies, J&J found those who got the drug had a rapid reduction in the severity of their thinking, although the results didn't differ in a statistically significant way from patients given a placebo.


America has been in the throes of a suicide crisis even before the pandemic, with the rate rising 30% from 1999 to 2016. Covid-19 closures limited the number of people given the spray as a depression treatment in-person at specified centers.

Ultimately, though, the numbers improved as patients and centers adapted and concerns grew within the mental health community that physical distancing and social isolation of quarantine may exacerbate people's existing problems or introduce new ones.

"Relatively rapidly within a few weeks we saw the numbers stabilize, which was pretty interesting for us and validating in the sense that clinic and patients alike were continuing to make this available," Kramer said. "We certainly see more and more sites sign on and more and more patients are treated."

Spravato is a close chemical cousin of the anesthetic ketamine, which differs from existing antidepressants because it acts on the glutamate system in the brain rather than on seratonin or norepinepherine. Scientists have been working to better understand how the drug helps patients and why it works so quickly.

The drug's approval last year marked the first major breakthrough for depression since 1987. President Donald Trump has since trumpeted the drug as having the potential to curb veteran suicides, but a Veterans Affairs medical panel only approved the drug's use on a limited basis.

[Joe Guy]

So what do you do? Call your doctor and tell him you might need a prescription because you’re about to jump off a bridge?

[Gob]

Part of the thinking behind the decision was that Spravato's ability to act quickly could mean it works differently than older antidepressants that can take weeks to kick in, Kramer said. In its studies, J&J found those who got the drug had a rapid reduction in the severity of their thinking, although the results didn't differ in a statistically significant way from patients given a placebo.

Sounds like they were given hope.

[ex-khobar Andy]

In its studies, J&J found those who got the drug had a rapid reduction in the severity of their thinking, although the results didn't differ in a statistically significant way from patients given a placebo.

The only thing I can conclude from that is that it's a real example of the placebo effect. If you are contemplating suicide and you know that there is a drug for that, call 911 and someone will come running with the pill and you pop it. And you put the weapon back on the shelf: hey presto! the drug worked. Well, no: it's the act of calling for help that did the job. Makes sense to me.

They could probably use the yellow M&Ms - hell, no-one likes them - and market them as an anti-suicide drug. They would, like this compound, not differ from the placebo: but it would be as effective and do the world a favor at the same time.